A Phase 3 Multicenter, Open Label, Randomized Study of XL119 Versus 5-Fluorouracil (5-FU) Plus Leucovorin (LV) in Subjects With Advanced Biliary Tumors Not Amenable to Conventional Surgery

Inclusion Criteria:

- Male and female subjects with advanced histologically confirmed biliary cancer
(gallbladder cancer or cholangiocarcinoma) that is not amenable to conventional
surgical approach

- 18 years or older

- Life expectancy of at least 12 weeks

- Eastern Cooperative Oncology Group (ECOG) Performance Status score less than 3

- Willing and able to sign informed consent

- Sexually active men and women must use an accepted and effective method of
contraception (including barrier contraception with spermicide)

- Women of child-bearing age must have a negative pregnancy test

- Laboratory criteria

Exclusion Criteria:

- Prior chemotherapy (excluding chemotherapy given as adjuvant treatment completing
more than 6 months prior to entry into study)

- Unstable angina, or class III or IV New York Heart Association heart disease

- Central nervous system metastases

- Uncontrolled diabetes mellitus

- Uncontrolled seizure disorder

- Major surgery, chemotherapy, immunotherapy, or radiotherapy during the 28 days
preceding the first study treatment

- Need for concomitant anticancer therapy (chemotherapy, immunotherapy, or radiation)
or other investigational agents during study participation or 28 days prior to study
participation

- Pregnant or breast-feeding

- A known history of human immunodeficiency virus (HIV) infection